Ethical, Technical, and Regulatory Challenges
摘要
This chapter confronts the consequential challenges facing responsible AI-haptic deployment. It addresses data privacy risks unique to continuous biometric streams, emphasizing technical controls such as federated learning and differential privacy. Ethical discussions focus on clinician dependency, deskilling, and algorithmic bias. The chapter also provides a roadmap for navigating international regulatory pathways, specifically the EU MDR (2017/745) and the FDA’s SaMD framework. It concludes by addressing the socioeconomic barriers to adoption, advocating for global health equity and design-for-equity principles.